A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension

October 7, 2013 updated by: Allergan
This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular pressure (IOP) lowering medication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ocular hypertension or glaucoma in at least 1 eye
  • Visual acuity of 20/100 or better in both eyes

Exclusion Criteria:

  • Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s)
  • Intraocular or glaucoma surgery in the past 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ALPHAGAN® P and LUMIGAN®
1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
Drug: 0.1% brimonidine tartrate ophthalmic solution
1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.
Other Names:
  • ALPHAGAN® P
Drug: 0.01% bimatoprost ophthalmic solution
1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
Other Names:
  • LUMIGAN®
Drug: latanoprost 0.005% ophthalmic solution
1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.
Active Comparator: LUMIGAN® Alone
1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
Drug: 0.01% bimatoprost ophthalmic solution
1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
Other Names:
  • LUMIGAN®
Drug: latanoprost 0.005% ophthalmic solution
1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.
Drug: 0.2% hypromellose lubricant eye drops
1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.
Other Names:
  • GenTeal ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)
Time Frame: Baseline, Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

January 31, 2012

First Posted (Estimate)

February 2, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

October 7, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMA-LUM-11-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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